USDFA concludes audit at Indoco’s Goa Plant I
Deepthi | Myequity news | Date : 28-01-2019 11:29:00 IST
The US Food and Drug Administration (USFDA) audit, which started on 17th January, 2019 at Indoco’s Goa Plant I (Oral Dosages Facility), concluded on 25th January, 2019 with the Regulatory Agency issuing 6 observations (483s) to the site. None of these observations are critical in nature. The Company will respond to these observations within the stipulated time of 15 days. About Indoco Remedies Limited:
Aditi Kare Panandikar, Managing Director, Indoco Remedies Limited commented, “Most of these observations are related to areas of improvement needed in documentation and review procedures. These observations / recommendations will help us further improve our quality systems in the plant, which in turn, will give a boost to revenues from the US market”.
Indoco Remedies Ltd., headquartered in Mumbai, is a fully integrated, research-oriented pharma Company with presence in 55 countries. The Company has 9 manufacturing facilities, 6 of which are for FDFs and 3 for APIs, supported by a state-of-the-art R&D Centre and a CRO facility. The facilities have been approved by USFDA, UK-MHRA, TGA-Australia, MCC-South Africa, etc. Indoco develops and manufactures a wide range of pharmaceutical products for the Indian and international markets.